Study to Assess the Efficacy, Safety, and Tolerability of SAR440340/REGN3500/Itepekimab in Chronic Obstructive Pulmonary Disease (COPD)
Completed · Phase 3 · NCT04751487
Conditions: Chronic Obstructive Pulmonary Disease
At a glance
- Research payments reported, 2025
- $1.4M
- U.S. investigators named
- 59
- Sites paid
- 50
- Planned or actual enrollment
- 1,234
About the trial
- Sponsor
- Sanofi (with Regeneron Pharmaceuticals)
- Tested
- Itepekimab SAR440340 (drug), Placebo (drug)
- Dates
- Started 2021-02-12; completion 2025-08-28
- Results posted
- Yes
Primary Objective: Primary population (former smokers cohort): \- Evaluate the efficacy of itepekimab compared with placebo on the annualized rate of acute moderate-or-severe COPD exacerbations in former smokers with moderate-to-severe COPD Secondary Objectives: Primary population (former smokers cohort): * Evaluate the efficacy of itepekimab compared with placebo on pulmonary function in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on occurrence of acute exacerbation of COPD (AECOPD) in former smokers with moderate-to-severe COPD * Evaluate the efficacy of itepekimab compared with placebo on severe AECOPD in former smokers with m…
From ClinicalTrials.gov, last updated 2026-10-09. Full record, eligibility and contacts (opens in a new tab)
Industry funding
Sanofi US Services Inc. reported $1.4M in research payments for this study in 2025 (221 payments).
Research payments usually go to hospitals, universities and research sites to run a study, not to the investigators personally. A payment is not evidence of wrongdoing.
U.S. investigators named on this study
- Phyllis S. Ritchie, MD Infectious Disease · Palm Springs, CA
- Ziad Tannous, MD Pulmonology · Palm Springs, CA
- David P. Pham, D.D.S. Dentists (general) · Aurora, CO
- Leonardo M. Allende, MD Family Medicine · Doral, FL
- Kwabena Ayesu, MD Internal Medicine · Orlando, FL
- Bradley M. Block, MD Family Medicine · Oviedo, FL
- Lourdes T. Bosch, MD Pulmonology · Miami, FL
- Jorge J. Calle Medina, M.D. Internal Medicine · Palm Springs, FL
- Jorge Diaz Valdes, MD Internal Medicine · Miami, FL
- Jose D. Gomez-cortes, M.D. Internal Medicine · Coral Gables, FL
- Joel Gonzalez, M.D. Internal Medicine · Homestead, FL
- Luis Hernandez Rosado, M.D. Internal Medicine · Pinecrest, FL
- Raj G. Karunakara, M.D. Pulmonology · Ocala, FL
- Daniel T. Layish, M.D. Pulmonology · Orlando, FL
- Sara N. Llerena, MD OB-GYN (Obstetrics & Gynecology) · Miami, FL
- Lon D. Lynn, D.O. Family Medicine · Tampa, FL
- Alberto Manzor, MD Internal Medicine · Pembroke Pines, FL
- Jesus Navarro, M.D. Nephrology (Kidney) · Tampa, FL
- Alexis R. Renta, M.D. Pain Medicine · Boynton Beach, FL
- Franklin D. Saumell, M.D. General Practice · Miami, FL
- Mohammad T. Sheikh General Practice · Lauderhill, FL
- Peruvemba S. Sriram, MD Pulmonology · Gainesville, FL
- Guy S. Strauss, D.O. Internal Medicine · Lake City, FL
- Miguel E. Trevino, MD PA Internal Medicine · Clearwater, FL
- Kirk G. Voelker, M.D. Critical Care Medicine · Sarasota, FL
- Neal Warshoff, D.O. Pulmonology · Loxahatchee, FL
- Jose Medina, MD Pulmonology · Valdosta, GA
- Ryan M. Brimeyer, DO Pulmonology · West Des Moines, IA
- Patrick E. Whitten, M.D. Pulmonology · Peoria, IL
- Salah Najm, MD Pulmonology · Topeka, KS
- Ketan P. Buch, MD Pulmonology · Lexington, KY
- David S. Green, M.D. Specialist · Shreveport, LA
- Robert Wise, M.D. Pulmonology · Baltimore, MD
- Vipul Jain, MD Anesthesiology · Ann Arbor, MI
- Chandar R. Abboy, M.D. Critical Care Medicine · Fayetteville, NC
- Selwyn Spangenthal, M.D. Pulmonology · Charlotte, NC
- Sugeet Jagpal, M.D. Pulmonology · New Brunswick, NJ
- Vishweshwar Ranga, M.D. Internal Medicine · Las Vegas, NV
- Ahmed Y. Khan, MD Pulmonology · Schenectady, NY
- Karin A. Provost, D.O., PHD Pulmonology · Williamsville, NY
- Anthony J. Smith, MD Pulmonology · New York, NY
- Robert M. Burkes Pulmonology · Cincinnati, OH
- Edward M. Cordasco, D.O. Pulmonology · Columbus, OH
- Jeremy Cole, MD Sleep Medicine · Edmond, OK
- Richard A. Mularski, MD, MCR, MSHS Pulmonology · Clackamas, OR
- Gerard Criner, MD Pulmonology · Philadelphia, PA
- Tiffany L. Dumont, D.O. Critical Care Medicine · Pittsburgh, PA
- Mohamed A. Turki, MD Pulmonology · Bethlehem, PA
- Alvaro U. Aranda- Rodriguez, MD Pulmonology · Guaynabo, PR
- Pedro F. Del Valle De Tomas, MD Internal Medicine · San Juan, PR
- Jesus W. Rodriguez Rodriguez, M.D. General Practice · Ponce, PR
- Carl I. Mitchell, M.D. Internal Medicine · Columbia, SC
- Yasir Ahmed, M.D. Internal Medicine · Victoria, TX
- Ali M. Bajwa, M.D. Family Medicine · Houston, TX
- Carl E. Dukes, MD Nephrology (Kidney) · San Antonio, TX
- David Fuentes, MD Allergy & Immunology · Boerne, TX
- Vanna S. Gold, D.O. Family Medicine · Lampasas, TX
- Sinikka L. Green, MD Emergency Medicine · Austin, TX
- Maria R. Boustani, MD Pulmonology · Beckley, WV
Clinicians the company named as principal investigators in its Open Payments reports.
Sites paid to run it
- Care Access Research Llc $416,983
- Pines Care Research Center Llc $92,960
- Beautiful Minds Medical Center Llc $80,266
- Elligo Health Research Inc $76,196
- Direct Helpers Medical Center Inc Direct Helpers Research Center $56,408
- Finlay Medical Research Corp $55,468
- Johns Hopkins University $53,924
- Interspond LLC $53,731
- Allegheny Singer Research Institute $44,421
- Allianz Research Institute Co Llc $42,054
- My Community Research Center Inc $30,825
- University of Cincinnati $28,912
- UCSF Langley Porter Psychiatric Hospital and Clinics, CA $24,701
- Lfros Research Llc $21,706
- Kaushlendra Tripathi Medtrial Llc $19,814
- Medster Research Llc $17,020
- Newyorkpresbyterian Queens $16,998
- Omega Research Debary Llc $14,375
- Advanced Pulmonary Research Institute $12,580
- Genesis Clinical Research $12,425
- Innovation Medical Research Center, Inc $11,770
- North Florida Found for Research Education $11,075
- Innovative Research of West Florida $9,882
- St Lukes Hospital, PA $9,600
- Osf Heart of Mary Medical Center, IL $9,408
- Temple University of the Commonwealth System of Higher Education $9,348
- Ok Clinical Research LLC $9,080
- Sun Research Inst LLC $8,625
- American Health Research LLC $8,400
- Palmtree Clinical Research Inc $8,200
- Oviedo Medical Research $7,930
- Cotton Oneil Clinic Revocable Trust Cotton Oneil Clinical Research Center $7,732
- Sarasota Memorial Hospital, FL $7,200
- Clinical Research of West Florida $7,000
- Gmg Clinical Research Llc Radiance Clinical Research $6,579
- Renstar Llc Renstar Medical Research $6,450
- Buffalo Institute for Medical Research Inc $5,669
- Science Connections Llc $5,518
- Columbus Clinical Services $5,412
- Kaiser Foundation Hospital-Santa Clara, CA $4,850
- Innovo Research Inc $4,770
- Helix Biomedics Llc $4,750
- Wr Msra Llc $4,750
- Rutgers State University $4,650
- Adventhealth Medical Group Pulmonology at Orlando Ridgewood $4,320
- Brcr Medical Center Inc $2,600
- Lexington Biomedical Research Institute $2,500
- Qcare Site Services Inc $1,200
- Sierra Clinical Research $620
- Puerto Rico Consortium for Clinical Investigation $500
Sources: CMS Open Payments research payments (program year 2025) and ClinicalTrials.gov, U.S. National Library of Medicine.